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Changes and Associations Between Cervical Range of Motion, Pain, TMJ Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy

Primary Purpose

Migraine, Temporomandibular Joint Disorders, Myofascial Trigger Point Pain

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Aerobic exercise and exercise for TMJ
Aerobic exercise at home
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

37 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals diagnosed with migraine 2 or more years ago
  • Headache, occurring at least 6 times a year
  • Individuals from 18 years of age
  • Voluntary patient consent to participate in the study

Exclusion Criteria:

  • Neurological or psychiatric disorder
  • Visiting an orthodontist, taking muscle relaxants
  • Head or neck injury, cervical spine hernia, facial or temporomandibular injury

Sites / Locations

  • Lithuanian University of Health Sciences, Department of Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Intervention group (n=10) received 12 physiotherapy sessions and exercises for TMJ 30-45 minutes 2 days per week.

Control group (n=9) was introduced with physiotherapy program in order to perform it independently at home.

Outcomes

Primary Outcome Measures

Goniometry for cervical range of motion
Cervical flexion (45⁰), extension (35⁰) and lateral flexion (45⁰) were measured with mechanical goniometer.
Algometry for pressure pain thresholds (PPT)
PPT were measured in temporalis, upper trapezius and masticatory muscles with digital algometer in kg/cm²

Secondary Outcome Measures

Anthropometry for TMJ
TMJ range of motion was measured with a centimeter before and after physiotherapy
Functional health and well-being - SF-36v2®
Quality of life was assessed with the SF-36 questionnaire. Measure is divided into 8 subscales: Physical Functioning, Activity Limitation due to Physical Ailments, General Health, Vitality, Social Functioning, Activity Limitation due to Emotional Problems, General Mental Health and Health Transition. Answers were scored (total score 100) and a higher total score meant a better quality of life.

Full Information

First Posted
January 21, 2021
Last Updated
January 27, 2021
Sponsor
Lithuanian University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04729699
Brief Title
Changes and Associations Between Cervical Range of Motion, Pain, TMJ Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy
Official Title
Changes and Associations Between Cervical Range of Motion, Pain, Temporomandibular Joint Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
August 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular joint (TMJ) movements and quality of life in individuals with migraine.
Detailed Description
Migraine is one of the most common type of headaches in the world causing the greatest disability in individuals under 50 years of age. Many different health organizations (American Headache Society etc.) recommend regular physical activity and exercise for the treatment and prevention of migraine. However, the relationship between aerobic exercise and migraine is still not completely clear. Unfortunately, a research database to validate the benefits of exercise for people with migraine is still being developed. The aim of this study is to assess the effects of physiotherapy program and review the associations between neck movements, pain, temporomandibular movements and quality of life in individuals with migraine. The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2020-06-30 No.BEC-SR(M)-266).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Temporomandibular Joint Disorders, Myofascial Trigger Point Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants were divided into intervention group and control group.
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention group (n=10) received 12 physiotherapy sessions and exercises for TMJ 30-45 minutes 2 days per week.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group (n=9) was introduced with physiotherapy program in order to perform it independently at home.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise and exercise for TMJ
Intervention Description
Aerobic exercise
Intervention Type
Other
Intervention Name(s)
Aerobic exercise at home
Intervention Description
Aerobic exercise
Primary Outcome Measure Information:
Title
Goniometry for cervical range of motion
Description
Cervical flexion (45⁰), extension (35⁰) and lateral flexion (45⁰) were measured with mechanical goniometer.
Time Frame
Baseline to 6 weeks
Title
Algometry for pressure pain thresholds (PPT)
Description
PPT were measured in temporalis, upper trapezius and masticatory muscles with digital algometer in kg/cm²
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Anthropometry for TMJ
Description
TMJ range of motion was measured with a centimeter before and after physiotherapy
Time Frame
Baseline and after 6 weeks
Title
Functional health and well-being - SF-36v2®
Description
Quality of life was assessed with the SF-36 questionnaire. Measure is divided into 8 subscales: Physical Functioning, Activity Limitation due to Physical Ailments, General Health, Vitality, Social Functioning, Activity Limitation due to Emotional Problems, General Mental Health and Health Transition. Answers were scored (total score 100) and a higher total score meant a better quality of life.
Time Frame
Baseline and after 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
37 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals diagnosed with migraine 2 or more years ago Headache, occurring at least 6 times a year Individuals from 18 years of age Voluntary patient consent to participate in the study Exclusion Criteria: Neurological or psychiatric disorder Visiting an orthodontist, taking muscle relaxants Head or neck injury, cervical spine hernia, facial or temporomandibular injury
Facility Information:
Facility Name
Lithuanian University of Health Sciences, Department of Rehabilitation
City
Kaunas
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Changes and Associations Between Cervical Range of Motion, Pain, TMJ Range of Motion and Quality of Life in Migraineurs Applying Physical Therapy

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